ARTICLE SUMMARY:
In this week’s Pathways Picks: Australia circulates a consultation on proposed regulatory updates to address artificial intelligence, EU nominates health commissioner, Brazil forms board to oversee clinical research, EU advances orphan device pilot, CMS opens coverage analysis for home ventilators, AMA publishes 2025 CPT codes, IMDRF gathers in Seattle, FDA finalizes decentralized trial guide, and dates to remember.
Global Picks
AI in Australia, and updates from the EU and Brazil:
Australia eyes AI updates. The Australian Therapeutic Goods Administration is seeking feedback on possible changes to its medical device rules to properly address rapidly evolving artificial intelligence-driven medtech. TGA published a consultation September 12 laying out possible updates to the Australia’s device classification rules, “essential principles,” and regulatory exclusions that would lead to tightened oversight in cases when AI algorithms are playing a more active role in prognosis and treatment. The consultation comes as part of a broader government endeavor to create “guardrails” around the deployment of AI in “high-risk settings.” Comments are due to TGA on October 13.
